BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT II 5ML WITH 24*1

    MDR report key: 9292666 · Received November 7, 2019

    Report

    Report Number
    2243072-2019-02494
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    October 23, 2019
    Report Date
    November 22, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿THERE IS BLOOD LEAKAGE AND THEY ARE FINDING IT DIFFICULT TO ASPIRATE¿ WITH LOT NUMBER 9182171 REGARDING ITEM # 300847 THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. DHR REVIEWED FOUND NO NON-CONFORMITIES. THE TEAM INVESTIGATED THE RETENTION SAMPLES OF MATERIAL NUMBER 300847 FOR BATCH NUMBER 9182171 AND DID NOT FIND LEAKAGE IN ANY OF THE 10 TESTED RETENTION SAMPLES. WE ALSO TRIED TO SIMULATE THE DEFECT ON MOLDING BUT WERE UNABLE TO RECREATE THE DEFECT. WE DID NOT FIND ANY SUCH SIMILAR DEFECT IN THE RETENTION SAMPLES. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE DISCARDIT II 5ML WITH 24*1 THERE IS BLOOD LEAKAGE. THIS OCCURRED ON 7400 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS BLOOD LEAKAGE AND THEY ARE FINDING IT DIFFICULT TO ASPIRATE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. BATCH NUMBER [9182171] WAS NOT FOUND FOR MATERIAL NUMBER [300847]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DISCARDIT II 5ML WITH 24*1 THERE IS BLOOD LEAKAGE. THIS OCCURRED ON 7400 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS BLOOD LEAKAGE AND THEY ARE FINDING IT DIFFICULT TO ASPIRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083330 DISCARDIT II 5ML WITH 24*1 SYRINGE FMF BECTON DICKINSON 9182171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other